GSK Announces Regulatory Submission Of Its Type 2 Diabetes Drug AlbigultideEditor's Choice
Main Category: Pharma Industry / Biotech Industry
Also Included In: Diabetes
Article Date: 15 Jan 2013 - 0:00 PST
GSK Announces Regulatory Submission Of Its Type 2 Diabetes Drug Albigultide
|Patient / Public:|
4.5 (2 votes)
GlaxoSmithKline has announced a regulatory submission to the U.S. Food and Drug Administration for its type 2 diabetes drug called albigultide.
The drug, which is taken once-weekly, is a a glucagon-like peptide-1 agonist (GLP-1 agonist). The peptide GLP-1 promotes insulin production which is vital for stabilizing blood sugar levels after a meal - those with diabetes aren't able to properly secrete this peptide.
Normal insulin production is restored among diabetics by taking Albiglutide, which contains two modified human copies of GLP-1 - enabling a longer duration of action.
GSK (GlazxoSmithkline) wrote in a communique that this represents yet another drug that the company has ready for review this year, illustrating the success and innovation of it's top-notch research and development team.
GSK plans on submitting albigultide for approval in the European Union within the next few months.
Albiglutide has not yet been approved as a treatment for type 2 diabetes or any other indication anywhere worldwide.
Other injectable GLP-1 class medications currently on the market include Byetta and Bydureon, from Bristol-Myers Squibb and Victoza, from Novo Nordisk.
The fact that the company is entering a market that is already fairly competitive means that the expected sales generated aren't going to phenomenal. It is predicted that the drug will bring in modest annual sales of only $367 million, according to Thomson Reuters.
Though there is a promising futureIn 2009, GSK completely reorganized its Research and Development in response to increased pressure in regards to the company's capacity to keep up with such a dynamic market, a move that's already showing promising results.
A string of other new drugs are ready to be submitted, such as the HIV medicine dolutegravir, their lung drugs Relvar and Anoro, and the melanoma medicines trametinib and dabrafenib.
Over the next couple of years GlaxoSmithKline will focus it's efforts on a whole new lineup of medications as it will anxiously be awaiting results from clinical trials of 14 of its new medicines. Two of which, Darapladib and MAGE-A3, could be ground-breaking and revolutionary treatments for heart disease and cancer.
Written by Joseph Nordqvist
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today
Regulatory update – GSK announces submission of albiglutide BLA to the US FDA for the treatment of type 2 diabetes
19 Jun. 2013. <http://www.medicalnewstoday.com/articles/254907.php>
Please note: If no author information is provided, the source is cited instead.
Contact Our News Editors
For any corrections of factual information, or to contact the editors please use our feedback form.
Please send any medical news or health news press releases to:
Note: Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care professional. For more information, please read our terms and conditions.